Back to search results

Exercise for Gut Microbiome in Young-Onset Colorectal Cancer During Chemotherapy

This study, called COURAGE, is looking at how a 12-week home-based exercise program affects the gut microbiome (the community of bacteria in your intestines) in people aged 18-50 with early-stage or metastatic colorectal cancer who are undergoing chemotherapy. Participants will be randomly assigned to either an exercise group, which includes a stationary bike, resistance bands, and virtual supervision, or a waitlist control group. Researchers will compare changes in the gut microbiome, chemotherapy side effects, and treatment outcomes between these two groups. The main goal is to see how the exercise program changes the gut microbiome.

Study design
This is a randomized controlled trial with two groups: an exercise group and a waitlist control group. About 84 people are expected to participate.
What's involved
You would participate for up to 6 months, which includes screening, blood tests, stool samples, and completing questionnaires. If in the exercise group, you would complete 36 virtually supervised exercise sessions over 12 weeks.
Compensation
Not stated in the trial record.
Follow-up
The primary endpoint, gut microbiome genomes, is measured at baseline (Week 1) and post-intervention (Week 13).

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT06202183

Exercise for Gut Microbiome in Patients With Young-Onset Colorectal Cancer Undergoing Chemotherapy: The COURAGE Trial

Recruiting
NAAges 18–50InterventionalSupportive care
Dana-Farber Cancer Institute
~84 participants
Updated 2026-08-19 on ClinicalTrials.gov
What's tested:Exercise Program

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Gut Microbiome Genomes
Measured over Baseline (Week 1) and Post-intervention (Week 13)

Conditions

Colorectal Cancer
Metastatic Colon Cancer
Metastatic Colorectal Cancer

Explore related trials

Colorectal Carcinoma

Where it's being run

1 sites across 1 states
Massachusetts1

Study leadership

  • Christina Dieli-Conwright, MPH, PhD · PRINCIPAL_INVESTIGATOR · Dana-Farber Cancer Institute

Who to contact

Christina Dieli-Conwright, MPH, PhD
[email protected]
617-582-8321
Email the study team

Opens a ready-to-send draft in your own email app — review before sending.

Do you actually qualify for this trial?

Add a private profile and we'll compare every criterion below against your situation — and tell you which ones are met, uncertain, or excluding.

Check eligibility for this trial ~2 min · HIPAA-protected · delete anytime
Eligibility criteria

Inclusion

Patient diagnosed with early-stage or metastatic colon or rectal cancer
Age at diagnosis 18-50 years; due to the specificity of the study question those outside the age bracket will not be included
No plans for major surgical intervention at the time of recruitment for a minimum of 12 weeks (i.e. study period; placement of port a cath is allowed)
No plans for radiation therapy at the time of recruitment for a minimum of 12 weeks
On or planning chemotherapy
Participate in less than or equal to 90 minutes of moderate-to-vigorous exercise per week
Medical clearance to perform exercise intervention and testing by their treating oncologist
No uncontrolled medical conditions that could be exacerbated with exercise
Ability to communicate and complete written forms in English
Ability to understand and the willingness to sign informed consent prior to any study-related procedures
Willing to travel to DFCI for necessary data collection

Exclusion

Participate in more than 90 minutes of moderate-to-vigorous aerobic exercise per week over the past month. This study targets insufficiently active persons to assess the effect of the described exercise intervention, where additional exercise done regularly will contaminate the intervention effects.
Unstable comorbidities that prevent participation in moderate-to-vigorous intensity exercise. Patients with unstable comorbidities may develop unexpected adverse events from exercise. For the purpose of patients' safety, as well as because this study involves remote, home-based exercise where close supervision is not possible, patients with unstable medical conditions are excluded.
Patients actively on a weigh loss diet and/or actively taking weight loss drugs. This could effect gut microbiome.
Patient with other active malignancies (excluding basal cell carcinoma).
Subjects who in the opinion of the investigator may not be able to comply with the safety monitoring requirements of the study.

What this trial measures

  • Gut Microbiome GenomesBaseline (Week 1) and Post-intervention (Week 13)

    Gut Microbiome Sequencing will be conducted using the stool samples at Baseline and Post-Intervention. Gut Microbiome sequencing will be performed using DNA and RNA extraction, which will analyze microbial genomes.